Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-28 @ 12:37 AM
Study NCT ID:
NCT06574061
Status:
COMPLETED
Last Update Posted:
2024-08-29
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Benefits of Sublingual AIT (PRACTIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1635}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PBQ (Patient Benefit Questionnaire)', 'timeFrame': 'V1 / V2 (6, 9 or 12 months after treatment initiation)', 'description': 'The Patient Benefit Questionnaire (PBQ) was used as the primary endpoint to evaluate the benefits perceived by patients.'}], 'secondaryOutcomes': [{'measure': 'PNQ (Patient Need Questionnaire)', 'timeFrame': 'V1 (at study inclusion)', 'description': 'The Patient Need Questionnaire (PNQ) was used to evaluate the expectations of patients regarding the prescription or new treatment(s) prescribed by the observing physicians.'}, {'measure': 'PBI Patient Benefit Index', 'timeFrame': 'Patient self-questionnaires returned at V1 (at study inclusion) and V2 (6, 9 or 12 months after treatment initiation)', 'description': 'The overall PBI score was calculated using the PNQ questionnaire at V1 (treatment expectations) and the PBQ questionnaire at V2 (treatment benefits).\n\nPBI is an index of the benefits perceived by patients with the AIT received. It considers patient expectations prior to AIT treatment and the perceived benefits after treatment.\n\nA PBI ≥1 is considered as indicating a relevant benefit of the AIT treatment for the patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SLIT treatment, patient adherence/satisfaction, PBI'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The objective of the study was to evaluate in routine practice the benefits of sublingual allergen immunotherapy (SLIT) for allergic patients with allergic rhinitis (AR), with or without asthma, according to various methods of use (treatment regimen: formulation type, dose, duration, initiation) and type of allergen (grass pollen, tree pollen, herbaceous pollen, house dust mites, animal dander, moulds and poly-reactive types).', 'detailedDescription': 'The treatment considered was any SLIT (tablet or liquid forms) accepted by the patient and the parent(s) in the case of minor patients. The treatment was taken as prescribed by the observing physician.\n\nThe expected benefits for patients after approximately 6 and 12 months after initiation of SLIT included:\n\n* Decreased intensity of symptoms\n* Decreased discomfort\n* Decreased consumption of symptomatic treatments or associated treatments (especially in asthmatic patients)\n* Improved quality of life\n* Reduced absenteeism from school or work\n* Beneficial impact on leisure activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target population included adult patients, adolescents and children (aged ≥5 years) with an allergy to one or more allergens confirmed by a positive skin prick-test and/or the presence of specific IgE antibodies, and eligible for AIT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 5 years or older\n* Patients with a respiratory allergy with significant clinical symptoms and whose diagnosis was confirmed by a positive skin prick-test and/or the presence of specific IgE antibodies to one or more allergens implicated in the symptoms\n* Patients eligible for AIT (patients who had been treated with AIT in the 3 years prior to the inclusion visit could be included if starting a new form and/or type of AIT)\n* Patients previously treated with a pharmacological AR treatment in the month before the inclusion visit or during the previous pollen season, and requiring the initiation of AIT\n* Patients (and/or their parents or legal representatives as appropriate) agreeing to take part in the study after having been informed orally and in writing by the observing physician.\n\nExclusion Criteria:\n\n* Patient with a hypersensitivity (allergy) to any of the excipients in the selected AIT\n* Patients taking beta-blockers (including local treatments, e.g. eye drops)\n* If asthmatic patient:\n* Patients with uncontrolled (unstable) or severe asthma (in adults this was defined as daily symptoms and FEV1 \\<70% of the theoretical value after appropriate drug treatment, and in children and adolescents by FEV1 \\<80% of the theoretical value after appropriate drug treatment)\n* Patients who have had a severe asthma exacerbation in the last three months\n* Asthmatic patient with unresolved acute infection of the airways.'}, 'identificationModule': {'nctId': 'NCT06574061', 'acronym': 'PRACTIS', 'briefTitle': 'Evaluation of the Benefits of Sublingual AIT (PRACTIS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stallergenes Greer'}, 'officialTitle': 'Evaluation in Routine Practice of the Benefits of Sublingual Allergen Immunotherapy in Allergic Patients According to Different Modalities of Use', 'orgStudyIdInfo': {'id': 'OTH-PES-08-FR'}}, 'contactsLocationsModule': {'locations': [{'zip': '92160', 'city': 'Antony', 'country': 'France', 'facility': 'Stallergenes Greer', 'geoPoint': {'lat': 48.75329, 'lon': 2.29668}}], 'overallOfficials': [{'name': 'Pascal DEMOLY, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU & IDESP, Montpellier, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stallergenes Greer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}